Preliminary study of a novel artificial anal sphincter with perception reconstruction.

Background: Artificial anal sphincter (AAS), as an advanced device, has been widely investigated by researchers around world. But the reliability of the structure is still unsatisfactory according to clinical results. What's more, the previous AAS systems are lack the ability of rectal perception as native anal sphincter, which fails to guarantee the safety of the blood supply. In addition, without it, the patient cannot determine when to defecate.

Methods: In order to improve the reliability and safety of current AAS systems, a novel structure AAS system with rectal perception function, based on pressure sensor module, is proposed in this article. The novel AAS system has a closed three-arm clamping mechanism, with transmission structure of cam-follower system. Then, the design, strength check, optimization and force analysis of the proposed mechanism are investigated. After that, to remodel rectal perception function, the novel sensor module system based on strain gauge is established. Finally, in vitro experiments are conducted.

Results: In vitro test, the sensor system could monitor the rectal pressure accurately. And when H = 24.6 cm (feeling the urge to have a bowel movement), the clamping pressure is 7.39 kPa. which is also less than the safe pressure 9.33 kPa.

Conclusions: Good performance of the reliability and safety of both novel rectal perception function and new clamping mechanism have been showed.